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FDA Clears Quidel MDx HSV 1+2 Test

NEW YORK (GenomeWeb News) – Quidel announced after the close of the market on Thursday the 510(k) clearance by the US Food and Drug Administration of the company's AmpliVue HSV 1+2 Assay for differentiating and detecting herpes simplex viruses 1 and 2.

The assay is for use on Quidel's handheld AmpliVue molecular diagnostic device and requires no upfront DNA extraction. Results can be obtained in about one hour, the San Diego-based company said.

The assay is the third AmpliVue assay to be launched by Quidel. The AmpliVue C. difficile assay was cleared by the FDA in late 2012, while the AmpliVue GBS Assay for the molecular detection of Group B Streptococcus was cleared in 2013. Other assays remain in development, Quidel said.